JPS6158661A - Blood purifier - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION [Technical Field] The present invention relates to blood purifiers such as adsorption type blood purifiers and membrane type surface liquid purifiers such as hollow membranes. More specifically, the present invention relates to a blood purifier substantially liquid-tightly filled with water or an aqueous solution.

[Prior art] In recent years, adsorption type blood purifiers have been used for blood purification, but many of the blood purifiers were originally liquid-tight inside the container, but air bubbles are generated due to long-term storage. can be found. When such a blood purifier is used on a patient, various problems occur such as blood coagulation, hemolysis, and decreased performance. Therefore, measures are desired to prevent air bubbles from getting mixed in, and various improvements have been made to the sealing portion of the container.

For example, in the case of a sealed plug made of silicone rubber, the wall is thick to prevent the plug from slipping, or it is thin and has a spherical tip to withstand the expansion of the internal liquid due to rising temperatures. Both are insufficient to prevent air bubbles from entering during long-term storage.

[Object of the Invention] The object of the present invention is to solve the problem of bubble generation in such a blood purifier, and to provide an excellent blood purification device that does not generate bubbles even during long-term storage and does not cause problems such as white liquid coagulation during use. It is about providing the equipment.

[Structure of the Invention] The present invention provides a blood purifier having a container incorporating a blood purification function section, a blood introduction section, a blood outlet section, and a sealing member for the introduction/exit section. It has a structure that can expand and contract depending on the amount of water or an aqueous solution, and is sealed in a substantially liquid-tight state filled with water or an aqueous solution, and the structure is capable of shrinking as the filling liquid decreases. Regarding blood purifiers.

The present invention will be explained in more detail below.

The blood purifier in the present invention includes artificial kidney 9 artificial liver 2
This includes anything that has a blood purification function, such as a serum separator or a blood filter. Examples of the blood purification function part built into the container include an adsorption type using an adsorbent, a model using a hollow fiber membrane, a flat membrane, a tubular membrane, etc. For example, a dialysate introduction part, a dialysate outlet part, etc. may be further provided.

These introducing/exiting parts are provided with sealing members, and the sealing members may be provided independently in each introducing/exiting part, or may be provided in a state connected to a plurality of introducing/exiting parts.

The present invention provides such a blood purifier, which has a structure that can expand and contract in response to increases and decreases in internal pressure, and is sealed in a substantially liquid-tight state filled with water or an aqueous solution, and which is sealed in a substantially liquid-tight manner. The structure is characterized by shrinking as the structure decreases.

That is, the blood purifier is filled with water or an aqueous solution in a substantially liquid-tight manner. Such water or aqueous solution is harmless to the human body, and examples thereof include distilled water, physiological saline, and the like. In addition, a state in which the internal space is filled in a substantially liquid-tight manner means that the internal space is completely filled with liquid, and the other is the case where the internal space is completely filled with liquid, and the case where there is space inside a blood purification function member such as an adsorbent or membrane, or a space for dialysate other than blood. This means that air remains in the area. In other words, at least in the space where blood circulates,
I+ means completely filled with water or aqueous solution.

Further, the blood purifier of the present invention has an expandable and deflated structure that increases the internal volume of the blood purifier. That is, as shown in FIG. 1, a container 1° containing an adsorbent 4, a blood introduction part 2. Blood lead-out section 3. This is an adsorption type blood purifier having a sealing member 5 and a structure 10 that can be expanded and contracted. Incidentally, an example of a structural part that can be expanded and contracted is the structural part 11. shown in FIG. 12° shown in Figure 3; 13° shown in Figure 4. and 14 shown in FIG. 5. FIG. 4 shows a hollow fiber membrane type blood purifier in which a hollow fiber membrane 6 is built into a container 1 and has a dialysate inlet 7 and a dialysate outlet 8.

Such an expandable/contractable structure of the present invention allows the water filled in the blood purifier to pass through a sealing member, a sealing part, etc. and evaporate outside the blood purifier, and furthermore, to evaporate inside the blood purifier. We focused on the fact that air bubbles are generated in the purifier by passing through the sealing member etc. because the pressure of the air becomes lower than the atmospheric pressure, and even if the water evaporates, the amount of filling liquid decreases. This structure is designed to prevent the pressure inside the container from becoming lower than atmospheric pressure due to the contraction of the structure.

That is, a specific example of the structure is a part of a container as shown in FIGS. 1, 3, 4, and 5.

A bellows-shaped thing provided on at least a part of the inlet/outlet pipe or a sealing member, a dupe that is used as a sealing member as shown in Fig. 2 and is flattened at least in part, and a thing that is used as a sealing member. Examples include those in the shape of a cap or balloon, and those in which at least a portion of the container or inlet/outlet is thin and expandable.

Regarding the form of the structural part, it is difficult to make it liquid-tight with just a balloon-shaped sealing member, so it is most preferable to use a structure that is liquid-tight and easy to melt-seal, such as a flat duplex. preferable. The structure also includes at least one blood purifier.
Any type of sealing member may be used as long as it is provided in some places.

The material forming this structure may be any material as long as it can expand and contract in response to increases and decreases in the pressure within the purifier, and materials with excellent biocompatibility are preferred. Specific examples of such materials include silicone rubber and polyvinyl chloride.

The culm has a large change in internal volume due to expansion or contraction of the structure, and is highly effective in preventing air bubbles from entering.

Further, the blood purifier of the present invention may have an internal pressure at normal pressure, but it is more preferable that the blood purifier is maintained at a pressure higher than atmospheric pressure. That is, if the internal pressure is maintained higher than atmospheric pressure and the expandable/contractable structure is kept in an expanded state, if the filling volume decreases due to water evaporation, etc. By contracting the structure following the decrease in volume, it is possible to more easily prevent the internal pressure from falling below atmospheric pressure and the incorporation of air bubbles.

The internal pressure of the blood purifier of the present invention is at least atmospheric pressure, preferably at least 0.01 Kg/cm G;
= Preferably 1 h/cM Q, 0.5
kg/rfflG is more preferable, especially 0.2 to 9/rfflG.
cMG is preferred. Also, the internal volume (Vl) when the inside of the blood purifier is pressurized and the internal volume when the inside is under normal pressure.
V2) difference (V+ - V2) is 0 after long-term storage.
．． It is desirable that the range is from 0.05 to 10 cc, more preferably from 0.1 to 5 cc, and especially from 0.1 to 5 cc. Preferably 0,2
~2CC.

In addition, the blood purifier of the present invention is in a sterilized state.
It's good because it can be used as is. For the sterilization method (a), heat sterilization at high temperature and high pressure is preferable, and heat sterilization can be performed in a liquid-tight sealed state, and the structure provides a buffering function for thermal expansion at that time, so it is easy to operate. is easy.

[Effects of the Invention] The blood purifier of the present invention does not contain air bubbles when stored for a long period of time, especially at high temperatures where water tends to evaporate, and therefore the blood purifier does not contain air bubbles during use. There is no risk of troubles such as blood coagulation, and this is an excellent product.

"Example" Regarding a blood purifier with a polypropylene container body having an internal volume of 500 cc, the sealing part is A; as shown in 11 in Fig. 2, a cylindrical stopper (made of vinyl chloride) is made into a flat shape with a mold, and then heated with hot water or 70 by steam
'C~130°C heat treated (thickness 1'rrL)
/m) B: Plug shaped like a bellows as shown in 10 in Figure 1 (material: vinyl chloride, wall thickness: 0.5771/m) C: Plug with the same shape as A (material: vinyl chloride), without flattening treatment A severe test was conducted on each of the specimens (thickness: 1 m/Tn) in a hot air dryer at a temperature of 60°C. However, at room temperature, the initial internal pressure and the internal volume difference (V+ - V2) from the normal pressure are approximately 0.1 Kg/cMG for △ and approximately 0 for 0.1 ccX3.
．． 1 to 9/ctA G.

0.15 cc, (te is approximately 0.19/cmG, approximately Qcc).

As a result, Δ and C were on the same weight loss straight line because they used sealed plugs with the same wall thickness and surface area, and the generation of bubbles was 14 days for C and 36 days for A.

Regarding B, since the wall thickness of the sealing part was thinner than A and C and the surface area was larger, the weight loss was large and bubbles were generated after 32 days.

[Brief explanation of drawings]

1 to 5 illustrate the blood purifier of the present invention. 1 is a container, 2 and 3 are blood introduction ridges, 4 is an adsorption type blood purification function part, 5 is a parenchymal part, 6 is a hollow fiber membrane type blood purification function part, 7 and 8 are dialysate) 9 people. Department, 10.11.12.
13. and 14 are structural parts that can be expanded and contracted. Patent applicant Teijin Co., Ltd. Figure 1 Figure 3 Figure 4 Figure 5

Claims (1)

[Scope of Claims] 1. A blood purifier having a container with a built-in blood purification function part, a blood introduction part, a blood outlet part, and a sealing member for the inlet/outlet part; It has a structure that can expand and contract depending on the amount of water or an aqueous solution, and is sealed in a state where it is substantially liquid-tightly filled with water or an aqueous solution, and the structure is capable of shrinking as the filling liquid decreases. Blood purifier. 2. The blood purifier according to claim 1, wherein the structure is provided at a portion that comes into contact with blood. 3. The blood purifier according to claim 1, wherein the structure is provided in a sealing member.